Melanotan II vs Afamelanotide
It is an injection sold for a deep tan, less appetite and better erections. The only study had 3 men, and the rest is case reports of harm, including changing moles. An implant that lets people with a rare sun-pain disease stay in daylight longer. Trials in 168 adults show it works for that, but none show it works for tanning.
Afamelanotide has the stronger evidence, grade A (strong human evidence) against grade C for Melanotan II. Melanotan II: Not approved. Afamelanotide: FDA approved.
Evidence
CAnimal and cell studies
AStrong human evidence
Human studies cited
Animal or cell studies cited
Why the grade
The human evidence is a 1996 pilot phase 1 study in three men, plus case reports of melanoma and changing moles in users. No controlled trial of Melanotan II has been published for tanning or any other use.
Two randomized, double-blind, placebo-controlled trials in 168 adults with EPP (94 in the United States, 74 in the European Union) showed more pain-free hours in sunlight, and a 117-patient post-authorisation cohort followed for about two years confirmed the effect in routine practice. Consensus guidelines recommend it for preventing phototoxic symptoms. The evidence is strong for EPP and nonexistent for the tanning use the compound is also known for.
FDA
Not approved
Not approved by the FDA for any use and sold as an unregulated gray-market product. Melanotan II was nominated for the FDA's list of substances compounding pharmacies may use and placed in Category 2 (significant safety risk); the nomination was withdrawn and the FDA removed it from that category in April 2026, with an advisory committee review planned, which does not make it legal to compound or sell.
FDA approved
Afamelanotide is FDA-approved and sold as Scenesse, a subcutaneous implant, approved in October 2019 to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). The European Medicines Agency authorised it for the same disease in 2014.
Sold for
Melanotan II is the 'Barbie drug' of gym and tanning culture, sold online as an injectable that gives a deep tan, suppresses appetite, and improves erections.
Afamelanotide is best known as the first drug for EPP, a rare disease in which sunlight causes burning pain, and in its earlier life as a candidate 'sunless tan' because it darkens skin.
Studies say
A three-man pilot study in 1996 showed it darkens skin and causes erections and nausea, and the rest of the literature is case reports of harm, which is grade C evidence.
Randomized trials show it lengthens the time EPP patients can spend in sunlight without pain, which earns grade A for that indication; there are no trials supporting cosmetic tanning.
Class
Melanocortin agonist (MC1R/MC3R/MC4R)
MC1R agonist
Route
Injection
Implant